PMID- 35713499
OWN - NLM
STAT- MEDLINE
DCOM- 20221227
LR  - 20230322
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Print)
IS  - 1462-0324 (Linking)
VI  - 62
IP  - 1
DP  - 2022 Dec 23
TI  - COVID-19 vaccination-related adverse events among autoimmune disease patients: 
      results from the COVAD study.
PG  - 65-76
LID - 10.1093/rheumatology/keac305 [doi]
LID - keac305
AB  - OBJECTIVES: COVID-19 vaccines have been proven to be safe in the healthy 
      population. However, gaps remain in the evidence of their safety in patients with 
      systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 
      vaccination-related adverse events (AEs) in patients with SAIDs and healthy 
      controls (HC) seven days post-vaccination were assessed in the COVAD study, a 
      patient self-reported cross-sectional survey. METHODS: The survey was circulated 
      in early 2021 by >110 collaborators (94 countries) to collect SAID details, 
      COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent 
      vaccination status. Analysis was performed based on data distribution and 
      variable type. RESULTS: Ten thousand nine hundred respondents [median 
      (interquartile range) age 42 (30-55) years, 74% females and 45% Caucasians] were 
      analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. 
      Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent 
      medical attention (but not hospital admission) overall. Headache [SAIDs = 26%, 
      HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain 
      [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness 
      [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly 
      more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% 
      CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, 
      HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs 
      though absolute risk was small (0-4%). Major AEs and hospitalizations (<2%) were 
      comparable across vaccine types in SAIDs. CONCLUSION: Vaccination against 
      COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than 
      HCs, though absolute risk was small. There are small differences in minor AEs 
      between vaccine types in SAID patients.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the 
      British Society for Rheumatology. All rights reserved. For permissions, please 
      email: journals.permissions@oup.com.
FAU - Sen, Parikshit
AU  - Sen P
AD  - Maulana Azad Medical College, New Delhi.
FAU - Ravichandran, Naveen
AU  - Ravichandran N
AUID- ORCID: 0000-0003-2014-3925
AD  - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate 
      Institute of Medical Sciences, Lucknow, India.
FAU - Nune, Arvind
AU  - Nune A
AUID- ORCID: 0000-0002-3849-614X
AD  - Southport and Ormskirk Hospital NHS Trust, Southport.
FAU - Lilleker, James B
AU  - Lilleker JB
AUID- ORCID: 0000-0002-9230-4137
AD  - Centre for Musculoskeletal Research, Division of Musculoskeletal and 
      Dermatological Sciences, School of Biological Sciences, Faculty of Biology, 
      Medicine and Health, Manchester Academic Health Science Centre, The University of 
      Manchester, Manchester.
AD  - Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance 
      NHS Foundation Trust, Salford, UK.
FAU - Agarwal, Vishwesh
AU  - Agarwal V
AD  - Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
FAU - Kardes, Sinan
AU  - Kardes S
AD  - Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, 
      Istanbul University, Istanbul, Turkey.
FAU - Kim, Minchul
AU  - Kim M
AD  - Center for Outcomes Research, Department of Internal Medicine, University of 
      Illinois College of Medicine Peoria, IL, USA.
FAU - Day, Jessica
AU  - Day J
AUID- ORCID: 0000-0001-8528-4361
AD  - Department of Rheumatology, Royal Melbourne Hospital.
AD  - Walter and Eliza Hall Institute of Medical Research.
AD  - Department of Medical Biology, University of Melbourne, Parkville, Victoria, 
      Australia.
FAU - Milchert, Marcin
AU  - Milchert M
AD  - Department of Internal Medicine, Rheumatology, Geriatrics and Clinical 
      Immunology, Pomeranian Medical University in Szczecin, Szczecin, Poland.
FAU - Gheita, Tamer
AU  - Gheita T
AUID- ORCID: 0000-0002-1155-9729
AD  - Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, 
      Cairo, Egypt.
FAU - Salim, Babur
AU  - Salim B
AD  - Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
FAU - Velikova, Tsvetelina
AU  - Velikova T
AD  - Department of Clinical Immunology, Medical Faculty, University Hospital 
      'Lozenetz', Sofia University St. Kliment Ohridski, Sofia, Bulgaria.
FAU - Gracia-Ramos, Abraham Edgar
AU  - Gracia-Ramos AE
AUID- ORCID: 0000-0003-1842-2554
AD  - Department of Internal Medicine, General Hospital, National Medical Center 'La 
      Raza', Instituto Mexicano del Seguro Social, Mexico City, Mexico.
FAU - Parodis, Ioannis
AU  - Parodis I
AUID- ORCID: 0000-0002-4875-5395
AD  - Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and 
      Karolinska University Hospital, Stockholm.
AD  - Department of Rheumatology, Faculty of Medicine and Health, Orebro University, 
      Orebro, Sweden.
FAU - Selva O'Callaghan, Albert
AU  - Selva O'Callaghan A
AUID- ORCID: 0000-0003-2823-9761
AD  - Internal Medicine Department, Vall D'hebron General Hospital, Universitat 
      Autonoma de Barcelona, Barcelona, Spain.
FAU - Nikiphorou, Elena
AU  - Nikiphorou E
AD  - Centre for Rheumatic Diseases, King's College London.
AD  - Rheumatology Department, King's College Hospital, London.
FAU - Chatterjee, Tulika
AU  - Chatterjee T
AD  - Center for Outcomes Research, Department of Internal Medicine, University of 
      Illinois College of Medicine Peoria, IL, USA.
FAU - Tan, Ai Lyn
AU  - Tan AL
AUID- ORCID: 0000-0002-9158-7243
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust.
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Leeds, UK.
FAU - Cavagna, Lorenzo
AU  - Cavagna L
AD  - Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Universita 
      degli studi di Pavia, Pavia, Italy.
FAU - Saavedra, Miguel A
AU  - Saavedra MA
AD  - Departamento de Reumatologia, Hospital de Especialidades Dr. Antonio Fraga 
      Mouret, Centro Medico Nacional La Raza, IMSS, Mexico City, Mexico.
FAU - Shinjo, Samuel Katsuyuki
AU  - Shinjo SK
AD  - Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, 
      Sao Paulo, Sao Paulo, Brazil.
FAU - Ziade, Nelly
AU  - Ziade N
AUID- ORCID: 0000-0002-4479-7678
AD  - Rheumatology Department, Saint-Joseph University.
AD  - Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
FAU - Knitza, Johannes
AU  - Knitza J
AUID- ORCID: 0000-0001-9695-0657
AD  - Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitatsklinikum 
      Erlangen, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Germany.
FAU - Kuwana, Masataka
AU  - Kuwana M
AUID- ORCID: 0000-0001-8352-6136
AD  - Department of Allergy and Rheumatology, Nippon Medical School Graduate School of 
      Medicine, Bunkyo-ku, Tokyo, Japan.
FAU - Distler, Oliver
AU  - Distler O
AUID- ORCID: 0000-0002-0546-8310
AD  - Department of Rheumatology, University Hospital Zurich, University of Zurich, 
      Zurich, Switzerland.
FAU - Chinoy, Hector
AU  - Chinoy H
AUID- ORCID: 0000-0001-6492-1288
AD  - Centre for Musculoskeletal Research, Division of Musculoskeletal and 
      Dermatological Sciences, School of Biological Sciences, Faculty of Biology, 
      Medicine and Health, Manchester Academic Health Science Centre, The University of 
      Manchester, Manchester.
AD  - National Institute for Health Research Manchester Biomedical Research Centre, 
      Manchester University NHS Foundation Trust, The University of Manchester, 
      Manchester.
AD  - Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS 
      Foundation Trust, Salford, UK.
FAU - Agarwal, Vikas
AU  - Agarwal V
AD  - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate 
      Institute of Medical Sciences, Lucknow, India.
FAU - Aggarwal, Rohit
AU  - Aggarwal R
AD  - Division of Rheumatology and Clinical Immunology, University of Pittsburgh School 
      of Medicine, Pittsburgh, PA, USA.
FAU - Gupta, Latika
AU  - Gupta L
AUID- ORCID: 0000-0003-2753-2990
AD  - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate 
      Institute of Medical Sciences, Lucknow, India.
AD  - Centre for Musculoskeletal Research, Division of Musculoskeletal and 
      Dermatological Sciences, School of Biological Sciences, Faculty of Biology, 
      Medicine and Health, Manchester Academic Health Science Centre, The University of 
      Manchester, Manchester.
AD  - Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, 
      Wolverhampton, UK.
CN  - COVAD Study Group
LA  - eng
GR  - 21992/VAC_/Versus Arthritis/United Kingdom
PT  - Journal Article
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - Female
MH  - Animals
MH  - Humans
MH  - Adult
MH  - Male
MH  - COVID-19 Vaccines/adverse effects
MH  - *COVID-19/prevention & control
MH  - Cross-Sectional Studies
MH  - *Simian Acquired Immunodeficiency Syndrome/etiology
MH  - Vaccination/adverse effects
MH  - *Autoimmune Diseases/epidemiology/etiology
PMC - PMC9214139
OTO - NOTNLM
OT  - COVID-19
OT  - adverse reaction
OT  - autoimmune disease
OT  - rheumatic disease
OT  - vaccine
FIR - Joshi, Mrudula
IR  - Joshi M
FIR - Barman, Bhupen
IR  - Barman B
FIR - Singh, Yogesh Preet
IR  - Singh YP
FIR - Ranjan, Rajiv
IR  - Ranjan R
FIR - Jain, Avinash
IR  - Jain A
FIR - Pandya, Sapan C
IR  - Pandya SC
FIR - Pilania, Rakesh Kumar
IR  - Pilania RK
FIR - Sharma, Aman
IR  - Sharma A
FIR - Manesh Manoj, M
IR  - Manesh Manoj M
FIR - Gupta, Vikas
IR  - Gupta V
FIR - Kavadichanda, Chengappa G
IR  - Kavadichanda CG
FIR - Patro, Pradeepta Sekhar
IR  - Patro PS
FIR - Ajmani, Sajal
IR  - Ajmani S
FIR - Phatak, Sanat
IR  - Phatak S
FIR - Goswami, Rudra Prosad
IR  - Goswami RP
FIR - Chowdhury, Abhra Chandra
IR  - Chowdhury AC
FIR - Mathew, Ashish Jacob
IR  - Mathew AJ
FIR - Shenoy, Padnamabha
IR  - Shenoy P
FIR - Asranna, Ajay
IR  - Asranna A
FIR - Bommakanti, Keerthi Talari
IR  - Bommakanti KT
FIR - Shukla, Anuj
IR  - Shukla A
FIR - Pandey, ArunKumar R
IR  - Pandey AR
FIR - Chandwar, Kunal
IR  - Chandwar K
FIR - Cansu, Dondu Uskudar
IR  - Cansu DU
FIR - Pauling, John D
IR  - Pauling JD
FIR - Wincup, Chris
IR  - Wincup C
FIR - Makol, Ashima
IR  - Makol A
FIR - Del Papa, Nicoletta
IR  - Del Papa N
FIR - Sambataro, Gianluca
IR  - Sambataro G
FIR - Fabiola, Atzeni
IR  - Fabiola A
FIR - Govoni, Marcello
IR  - Govoni M
FIR - Parisi, Simone
IR  - Parisi S
FIR - Bocci, Elena Bartoloni
IR  - Bocci EB
FIR - Sebastiani, Gian Domenico
IR  - Sebastiani GD
FIR - Fusaro, Enrico
IR  - Fusaro E
FIR - Sebastiani, Marco
IR  - Sebastiani M
FIR - Quartuccio, Luca
IR  - Quartuccio L
FIR - Franceschini, Franco
IR  - Franceschini F
FIR - Sainaghi, Pier Paolo
IR  - Sainaghi PP
FIR - Orsolini, Giovanni
IR  - Orsolini G
FIR - De Angelis, Rossella
IR  - De Angelis R
FIR - Danielli, Maria Giovanna
IR  - Danielli MG
FIR - Venerito, Vincenzo
IR  - Venerito V
FIR - Traboco, Lisa S
IR  - Traboco LS
FIR - Wibowo, Suryo Anggoro Kusumo
IR  - Wibowo SAK
FIR - Serrano, Jorge Rojas
IR  - Serrano JR
FIR - Garcia-De La Torre, Ignacio
IR  - Garcia-De La Torre I
FIR - Loarce-Martos, Erick Adrian Zamora Tehozol Jesus
IR  - Loarce-Martos EAZTJ
FIR - Prieto-Gonzalez, Sergio
IR  - Prieto-Gonzalez S
FIR - Gil-Vila, Albert
IR  - Gil-Vila A
FIR - Aranega, Raquel
IR  - Aranega R
FIR - Nakashima, Ran
IR  - Nakashima R
FIR - Sato, Shinji
IR  - Sato S
FIR - Kimura, Naoki
IR  - Kimura N
FIR - Kaneko, Yuko
IR  - Kaneko Y
FIR - Tomaras, Stylianos
IR  - Tomaras S
FIR - Gromova, Margarita Aleksandrovna
IR  - Gromova MA
FIR - Aharonov, Or
IR  - Aharonov O
FIR - Hmamouchi, Ihsane
IR  - Hmamouchi I
FIR - Hoff, Leonardo Santos
IR  - Hoff LS
FIR - Giannini, Margherita
IR  - Giannini M
FIR - Maurier, Francois
IR  - Maurier F
FIR - Campagne, Julien
IR  - Campagne J
FIR - Meyer, Alain
IR  - Meyer A
FIR - Nagy-Vincze, Melinda
IR  - Nagy-Vincze M
FIR - Langguth, Daman
IR  - Langguth D
FIR - Limaye, Vidya
IR  - Limaye V
FIR - Needham, Merrilee
IR  - Needham M
FIR - Srivastav, Nilesh
IR  - Srivastav N
FIR - Hudson, Marie
IR  - Hudson M
FIR - Landon-Cardinal, Oceane
IR  - Landon-Cardinal O
FIR - Shaharir, Syahrul Sazliyana
IR  - Shaharir SS
FIR - Zuleta, Wilmer Gerardo Rojas
IR  - Zuleta WGR
FIR - Silva, Jose Antonio Pereira
IR  - Silva JAP
FIR - Fonseca, Joao Eurico
IR  - Fonseca JE
FIR - Zimba, Olena
IR  - Zimba O
EDAT- 2022/06/18 06:00
MHDA- 2022/12/28 06:00
PMCR- 2022/06/17
CRDT- 2022/06/17 09:43
PHST- 2022/01/14 00:00 [received]
PHST- 2022/04/14 00:00 [revised]
PHST- 2022/06/18 06:00 [pubmed]
PHST- 2022/12/28 06:00 [medline]
PHST- 2022/06/17 09:43 [entrez]
PHST- 2022/06/17 00:00 [pmc-release]
AID - 6609762 [pii]
AID - keac305 [pii]
AID - 10.1093/rheumatology/keac305 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2022 Dec 23;62(1):65-76. doi: 
      10.1093/rheumatology/keac305.